The American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) [advocacy websites] on Tuesday asked [cert. petition, PDF; press release] the US Supreme Court [official website] to review the validity of patents on two genes associated with breast and ovarian cancers owned by a Utah company, Myriad Genetics [official website]. The patents at issue concern BRCA1 and BRCA2 [NCI backgrounder], isolated human genes that differ from native genes in that the process of extracting them results in changes in their molecular structure, although not in their genetic code. The ACLU argues that the process of isolating genetic material from a human DNA molecule does not make the isolated genetic material (cDNA) a patentable invention. The patents were held to be valid [JURIST report] in August by the US Court of Appeals for the Federal Circuit (CAFC) [official website]. The ALCU argues that the patents should be invalid based on the Supreme Court's ruling in Mayo Collaborative Services v. Prometheus Laboratories [opinion, PDF; JURIST report], in which it ruled that in order for something to be patentable it must add enough to a natural phenomena to make it different from anything found in nature.
The ACLU and PUPAT were concerned that these types of patents limit the amount of research that can be done and the availability of diagnostic tests associated with these genes to women in need. They filed a petition for certiorari [JURIST report] in the Supreme Court in 2011 after the Federal Circuit ruling that the patents were valid. The CAFC decisions run contrary to the position of the Obama administration, which in 2010 filed an amicus curiae brief [JURIST report] in support of the ACLU and PUBPAT. JURIST Guest Columnist Doreen Hogle [official profile] argued that the Mayo decision raised questions as to what innovations are subject to patent law protection and may result in stifled investment in technology [JURIST comment].